The purpose of this study is to demonstrate the non-inferior efficacy of TAK-438 versus lansoprazole in the treatment of participants with duodenal ulcer.
The drug being tested in this study is called TAK-438. TAK-438 is being tested to treat people who have duodenal ulcers and also may or may not have Helicobacter pylori (HP) infection. This study will look at duodenal ulcer healing and also the elimination of HP in people who take TAK-438 versus lansoprazole. The study will enroll approximately 530 patients. Participants were randomly assigned (by chance, like flipping a coin) to one of the two treatment groups-which remained undisclosed to the participant and study doctor during the study (unless there is an urgent medical need): * TAK-438 20 mg * Lansoprazole 30 mg HP+ participants will be asked to take a TAK- 438 tablet and a lansoprazole capsule twice daily in conjunction with bismuth-containing quadruple therapy for 2 weeks, followed up by a TAK-438 tablet and a lansoprazole capsule once daily for up to 4 weeks. HP negative (HP-) participants will be asked to take a TAK-438 tablet and a lansoprazole capsule once daily for up to 6 weeks. This multi-center trial will be conducted China, Korea and Taiwan. The overall time to participate in this study is up to 10 weeks. Participants will make multiple visits plus final visit at 2 weeks or 4 weeks after last dose of study drug for a follow-up assessment.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
533
TAK-438 tablets
Lansoprazole capsules
TAK-438 placebo-matching tablets.
Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcers
Endoscopic healing was defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.
Time frame: Week 4 or Week 6
Percentage of Helicobacter Pylori Infected (HP+) Participants With Successful HP Eradication After 4 or 6 Weeks of Treatment
HP infection status was determined by \^13C Urea Breath Test (\^13C-UBT). The urea breath test is used to detect infection with HP, a bacteria associated with stomach ulcers, by testing individual breath samples in a central laboratory.
Time frame: 4 weeks post treatment (Up to 10 weeks)
Percentage of Participants With Endoscopically Confirmed Healing of Duodenal Ulcer at Week 4
Endoscopic healing is defined as the disappearance of all white coats associated with duodenal ulcers as confirmed endoscopically.
Time frame: Week 4
Percentage of Participants With Posttreatment Resolution of Gastrointestinal Symptoms Associated With Duodenal Ulcer at Weeks 2 Through 6
The percentage of participants with resolution of various gastrointestinal symptoms are reported as categories. Gastrointestinal symptoms included epigastric pain (postprandial, fasting, nocturnal), abdominal bloating, nausea/vomiting, heartburn and lack of appetite. The severity of subjective symptoms of erosive esophagitis were recorded as: none = 0, mild = 1, moderate = 2 or severe = 3.
Time frame: Week 2 up to Week 6
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Lansoprazole placebo-matching capsules
1 g Amoxicillin, 500 mg clarithromycin and 600 mg bismuth potassium citrate/bismuth tripotassium dicitrate, twice daily (BID).
The First Affiliated Hospital of Anhui Medical University
Hefei, Anhui, China
Yijishan hospital of Wan nan Medical college
Wuhu, Anhui, China
Beijing Chao Yang Hospital
Beijing, Beijing Municipality, China
The General Hospital of People's Armed Police Forces China
Beijing, Beijing Municipality, China
The Central Hospital of China Aerospace Corporation
Beijing, Beijing Municipality, China
Beijing Friendship Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Beijing Tong Ren Hospital, Capital Medical University
Beijing, Beijing Municipality, China
Peking University First Hospital
Beijing,P.R., Beijing Municipality, China
The Second Affiliated Hospital of Chongqing Medical University
Chongqing, Chongqing Municipality, China
Fuzhou General Hospital of Nanjing Military Area Command of Chinese PLA
Fuzhou, Fujian, China
...and 71 more locations